(Reuters) – The U.S. Food and Drug Administration on Wednesday approved Mesoblast's (NASDAQ:) cell therapy to treat a type of complication that occurs after a stem cell or bone marrow transplant called graft-versus-host disease. (GVHD).
The therapy, called Ryoncil, is the first mesenchymal stromal cell therapy approved to treat pediatric patients two months of age and older whose GVHD symptoms have not responded to standard steroid therapy.
The company did not immediately respond to Reuters' request for comment on pricing and availability.
GVHD is a complication that can occur after a cell transplant, where the donated stem cells attack the recipient's cells, viewing them as an unknown threat.
Mesenchymal stromal cells are spindle-shaped cells that can have various functions in the body and can differentiate into many other cell types. The cells are isolated from the bone marrow of healthy adult human donors.
The FDA advises that the treating physician monitor the Ryoncil infusion and discontinue it if there is any evidence of a reaction such as difficulty breathing, low blood pressure, fever, or rapid breathing, among others.
Last year, the US health regulator refused to approve the therapy because it needed more data to support approval for its marketing.
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